跳至主要内容
临床试验/NCT02843750
NCT02843750撤回不适用

A Pilot Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery

Mayo Clinic1 个研究点 分布在 1 个国家开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
Mayo Clinic
试验地点
1
主要终点
Postoperative Pneumonia

研究概览

简要总结

To obtain definitive evidence for the effectiveness of a short preoperative inspiratory muscle training (IMT) protocol on the morbidity and recovery from an esophageal surgical resection.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
40 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All patients diagnosed with esophageal cancer and scheduled for esophageal resection at the Mayo Clinic Rochester with gastric conduit reconstruction -Cognitively capable to understand and perform a preoperative program
  • •Able to follow the intervention program for at least 2 weeks before surgery (surgery is usually scheduled 4 to 12 weeks after radiation)
  • •Willing to sign the informed consent form

排除标准

  • •Unable to communicate in the English language
  • •Participating in a conflicting trial concerning esophageal resection

研究组 & 干预措施

Inspiratory Muscle Training-Rehabilitation

Experimental

Patients will start the IMT-R, following their consent and within 2 weeks of their scheduled surgery: 10 sessions lasting about 90 minutes. Participants who completed their initial IMT greater than 2 weeks prior to surgery will have an additional visit prior to surgery. Participants will receive a Participant Manual demonstrating and explaining the rehabilitation process. Participants will also receive a log for recording their efforts and notes. A DVD of the rehabilitation is available to the participant. Participants will complete questionnaires at baseline and 3 months.

干预措施: Inspiratory Muscle Training-Rehabilitation (Behavioral)

Inspiratory Muscle Training-Rehabilitation

Experimental

Patients will start the IMT-R, following their consent and within 2 weeks of their scheduled surgery: 10 sessions lasting about 90 minutes. Participants who completed their initial IMT greater than 2 weeks prior to surgery will have an additional visit prior to surgery. Participants will receive a Participant Manual demonstrating and explaining the rehabilitation process. Participants will also receive a log for recording their efforts and notes. A DVD of the rehabilitation is available to the participant. Participants will complete questionnaires at baseline and 3 months.

干预措施: Questionnaires (Other)

结局指标

主要结局

Postoperative Pneumonia

时间窗: 3 months

To prospectively determine the effect of a customized preoperative inspiratory muscle training (IMT) and brief pulmonary rehabilitation program on the incidence of postoperative pneumonia in patients that undergo an esophageal surgical resection. The investigators will consider the following as pneumonia: new infiltrate + either fever (\>38.5 C) and white cell count \>11,000 or fever and purulent secretions.

次要结局

  • Postoperative Pulmonary Complications(3 months)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Roberto P. Benzo

MD

Mayo Clinic

研究点 (1)

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